Clinical Trial

A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

Active, Not Recruiting Phase 3
View on ClinicalTrials.gov →
Summary
A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)
Protocol Amendment History 5 amendments
This ClinicalTrials.gov record has been amended 5 times since 2021-07-02; most recent amendment 2026-05-22.
Status change: Recruiting → Active, Not Recruiting 2025-07-30
Status change: Not Yet Recruiting → Recruiting 2021-08-12
Trial Details
NCT Number NCT04951219
Lead Sponsor Madrigal Pharmaceuticals, Inc.
Conditions Non-Alcoholic Fatty Liver Disease
Enrollment 810 participants
Start Date 2021-07-09
Primary Completion 2027-03 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-05-27